Often, organizations use separate systems and processes for change control and variation management. Within Vault, an organization may use a Quality QMS Vault to ensure that a change to a product or system is introduced in a controlled and coordinated manner. The same organization may use a separate RIM Registrations Vault to determine the impacted markets for that change and manage the filing updates and approvals for relevant Health Authorities. In such a case, using separate systems can result in duplicate data entry and a lack of synchronization, which prolongs the process and results in changes that occur without a proper understanding of regulatory impact.
This feature enables organizations using both a QMS Vault and a Registrations Vault to share data about change events that have regulatory impact. The Quality to RIM Vault Connection automates data sharing between these two applications, supporting change control initiation, regulatory assessment, and close out.
About the Vault Connection
The Quality to RIM Vault Connection helps to solve several industry challenges that exist for change events, including:
- Regulatory Impact Assessments: When a change control Quality Event record is created in QMS, the connection creates an associated Event record in Registrations, including an option to map related impacted detail records such as products, active substances, and more. This allows Registrations users to start the impact assessment process. When the regulatory impact assessment is complete in Registrations, the connection pushes country-level details to QMS.
- Filing Updates: When the change control is approved for implementation in QMS, the connection automatically alerts country users in Registrations that they can begin their filings to get the change approved for all countries and relevant Health Authorities.
- Status Visibility: In QMS, users can gain visibility into the status of regulatory filing updates as updates occur in Registrations.
How the Quality to RIM Vault Connection Works
The Quality to RIM Vault Connection enables Vault to create and update records in a Registrations Vault after a user initiates a change event in a QMS Vault. The connection integrates data following this process:
- The connection starts in the QMS Vault. A QMS user creates a change control Quality Event record and determines that there may be regulatory impact. The user then creates a Change Control Impact Assessment record associated with the quality event. The QMS Vault sends a Spark message to the Registrations Vault to create an Event record with details about the change control.
- A Registrations user then determines the impact of the change control. The Registrations user completes a detailed impact assessment report for the new Event record and creates individual Activity records for each regulatory filing action that needs to occur to incorporate the new change. When the Registrations user moves the Event record to the next state, the Registrations Vault sends a Spark message to the QMS Vault.
- A QMS user then enters all details for the change management plan, including the regulatory filing actions to be implemented from the Registrations Vault’s Activity records. After the change plan is approved, the QMS user moves the change control Quality Event record to the Approved state. Vault sends a Spark message to the Registrations Vault to move the Event to a Ready for Implementation state.
- As each Activity record receives status updates from the related Health Authority, the Registrations Vault sends a Spark message to QMS. This allows QMS users to track the filing status for each impacted market.
- When a QMS user marks the Quality Event as complete, Vault sends a Spark message to the Registrations Vault to move the related Event to a Closed state.
If at any point during the process the Quality Event moves to a Cancelled state in the QMS Vault, Vault sends a Spark message to the Registrations Vault to move the related Event to a Cancelled state.
How to Sync Updated Data
Syncing Changes from Quality to RIM
If the scope of the change control is modified in your QMS Vault, you can sync changes to your Registrations Vault manually:
- Navigate to the Change Control Impact Assessment record in your QMS Vault.
- From the Actions menu, select Update RIM Change Details. This action may only be available in certain lifecycle states, depending on your Vault’s configuration.
- The QMS Vault sends a Spark message to the Registrations Vault to update the related Event record with new details about the change control. This may include updating fields on the Event record, as well as creating or inactivating related Event join records to align with related records that were added or deleted in the QMS Vault.
When you sync data between Vaults, Vault compares the Quality Event record’s ID and the Impact Assessment record’s ID to existing Event records in the Registrations Vault. If an existing Event record references these record IDs, Vault updates the existing record rather than creating a new one.
Syncing Changes from RIM to Quality
Your process may include reassessment of an event’s regulatory impact during the lifecycle of the change control. When there are changes to the regulatory impact assessment, you can sync updates to your QMS Vault manually:
- Navigate to the Event record in your Registrations Vault.
- From the Actions menu, select Update QMS Impact Details. This action may only be available in certain lifecycle states, depending on your Vault’s configuration.
- The Registrations Vault sends a Spark message to the QMS Vault to create, update, or inactivate Impacted Country records related to the change control. Vault may also update the related Change Control Impact Assessment record in the QMS Vault with details from the Event record in the Registrations Vault.